AIM ImmunoTech Announces Publication of Breast Cancer Data from Roswell Park Comprehensive Cancer Center in The Journal for ImmunoTherapy of Cancer
AIM ImmunoTech announced the publication of data from Roswell Park Comprehensive Cancer Center's Phase 1 study evaluating Ampligen® as part of a chemokine-modulating regimen in early-stage triple-negative breast cancer (TNBC). The study results, published in The Journal for ImmunoTherapy of Cancer, showed that the Ampligen-containing regimen can modify the tumor microenvironment and release cytokines that attract killer T-cells into early-stage TNBC tumors. Study principal investigator Dr. Shipra Gandhi noted the promising results while emphasizing the need for validation in a larger study.
AIM ImmunoTech ha annunciato la pubblicazione di dati dallo studio di Fase 1 del Roswell Park Comprehensive Cancer Center che valuta Ampligen® come parte di un regime di modulazione delle chemiochine nel cancro al seno triplo negativo (TNBC) in fase iniziale. I risultati dello studio, pubblicati nel The Journal for ImmunoTherapy of Cancer, hanno dimostrato che il regime contenente Ampligen può modificare il microambiente tumorale e rilasciare citochine che attraggono le cellule T killer nei tumori TNBC in fase iniziale. La principale investigatrice dello studio, la Dr.ssa Shipra Gandhi, ha sottolineato i risultati promettenti, evidenziando la necessità di una convalida in uno studio più ampio.
AIM ImmunoTech anunció la publicación de datos del estudio de Fase 1 del Roswell Park Comprehensive Cancer Center que evalúa Ampligen® como parte de un régimen de modificación de quimiocinas en el cáncer de mama triple negativo (TNBC) en etapa temprana. Los resultados del estudio, publicados en The Journal for ImmunoTherapy of Cancer, mostraron que el régimen que contiene Ampligen puede modificar el microambiente tumoral y liberar citoquinas que atraen células T citotóxicas a los tumores TNBC en etapa temprana. La investigadora principal del estudio, la Dra. Shipra Gandhi, señaló los resultados prometedores, enfatizando la necesidad de validación en un estudio más grande.
AIM ImmunoTech는 로스웰 파크 종합 암 센터(Roswell Park Comprehensive Cancer Center)의 1상 연구에서 Ampligen®을 초기 삼중음성 유방암(TNBC) 치료 요법의 일부로 평가한 데이터의 발표를 알렸습니다. The Journal for ImmunoTherapy of Cancer에 게재된 연구 결과는 Ampligen이 포함된 요법이 종양 미세환경을 수정하고 초기 TNBC 종양으로 킬러 T 세포를 유인하는 사이토카인을 방출할 수 있음을 보여주었습니다. 연구의 주요 연구자인 Shipra Gandhi 박사는 유망한 결과를 강조하면서 더 큰 연구에서의 검증 필요성을 강조했습니다.
AIM ImmunoTech a annoncé la publication de données provenant de l'étude de Phase 1 du Roswell Park Comprehensive Cancer Center évaluant Ampligen® dans le cadre d'un régime modulateur de chimiokines pour le cancer du sein triple négatif (TNBC) à un stade précoce. Les résultats de l'étude, publiés dans The Journal for ImmunoTherapy of Cancer, ont montré que le régime contenant de l'Ampligen peut modifier le microenvironnement tumoral et libérer des cytokines qui attirent les cellules T tueuses dans les tumeurs TNBC à un stade précoce. La principale investigatrice de l'étude, le Dr Shipra Gandhi, a noté les résultats prometteurs tout en soulignant la nécessité d'une validation dans une étude plus importante.
AIM ImmunoTech gab die Veröffentlichung von Daten aus der Phase-1-Studie des Roswell Park Comprehensive Cancer Center bekannt, in der Ampligen® als Teil eines chemokine-modulierenden Regimens für frühen triple-negativen Brustkrebs (TNBC) evaluiert wurde. Die im The Journal for ImmunoTherapy of Cancer veröffentlichten Studienergebnisse zeigten, dass das Ampligen-haltige Regime das Tumormikroenvironment verändern und Zytokine freisetzen kann, die Killer-T-Zellen in frühe TNBC-Tumoren anziehen. Die leitende Studieninvestigatorin Dr. Shipra Gandhi wies auf die vielversprechenden Ergebnisse hin und betonte die Notwendigkeit einer Validierung in einer größeren Studie.
- Phase 1 study showed promising results in treating aggressive triple-negative breast cancer
- Ampligen demonstrated ability to modify tumor microenvironment and attract killer T-cells
- Similar positive results observed in late-stage TNBC, advanced recurrent ovarian cancer and pancreatic cancer
- Small patient sample size requires validation in larger studies
- Still in early clinical phase (Phase 1) with no efficacy data presented
Insights
The publication of Phase 1 study results for Ampligen in triple-negative breast cancer (TNBC) represents a scientific milestone, but with immediate market impact. While the data suggests promising biological activity in modifying the tumor microenvironment, several key points warrant caution:
Key Findings:
- The study was conducted in a small patient population, requiring validation in larger trials
- The CKM regimen showed ability to attract killer T-cells into early-stage TNBC tumors
- Results align with previous observations in late-stage TNBC, ovarian and pancreatic cancers
The progression to Phase 2 trials, while positive, represents a standard development path with significant time and regulatory hurdles ahead. For a micro-cap company with
OCALA, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen® (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The Journal for ImmunoTherapy of Cancer.
“We are very excited with these promising results from our study of a new treatment combination for patients with this most highly aggressive form of breast cancer, triple-negative breast cancer,” said study principal investigator Shipra Gandhi, MD, Associate Professor of Oncology and staff physician in the Department of Medicine at Roswell Comprehensive Cancer Center. “Because this initial study was in a small number of patients, it will be important to validate these findings in a larger study.”
For more information on the data reported, please visit Roswell Park’s website to read its press release titled, “Roswell Park Clinical Trial Points Toward Promising New Therapy for Most Aggressive Type of Breast Cancer.”
AIM CEO Thomas K. Equels stated: “The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor. These data are similar to those we have seen with Ampligen previously in late-stage TNBC, advanced recurrent ovarian cancer and pancreatic cancer. We look forward to collaborating with Roswell Park as this study advances to Phase 2. We believe in the power of Ampligen to work in conjunction with a variety of chemotherapy regimens and/or immune checkpoint inhibitors.”
For more information about the study, please visit ClinicalTrials.com: NCT04081389.
About Roswell Park Comprehensive Cancer Center
From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for early-stage triple-negative breast cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
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